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TOPIC: Residual Solvents in Certificate of Analysis

Residual Solvents in Certificate of Analysis 6 years 4 months ago #6099

  • berrinice
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I wonder if anyone can tell me how much is a safe level of ethanol in Daclatasvir? I was wondering if 38% is too much? kindly
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6100

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whoops should red 0.38% ETHANOL .
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6101

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What is the source?
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6103

  • berrinice
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kingswood pharmacy in sydney
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6106

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I have just been diagnosed deficient B12 & folic acid associated with a) alcoholism or b) leukemia
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6107

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I have no idea. It is probably used in making the product. Being an alcohol, it probably just wasn't dried out quite all the way.
I just ordered that from them today. :)
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6108

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be very careful. I am going to get my money back
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6110

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the dickie batch no is 20150929
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6111

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berrinice wrote:
be very careful. I am going to get my money back

Why?
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6112

  • splitdog
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Why not call the pharmacy and ask them. They're open a few more hours.
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
The administrator has disabled public write access.

Residual Solvents in Certificate of Analysis 6 years 4 months ago #6116

  • sonix
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The Certificate of analysis I got from Kingswood for Dac says it should be less than 0.5%, so 0.38% is fine. My Dac came from the same batch.
M 61yo HCV+ ~ 30 yrs Gt1a F2 VL 223,000 ALT 54 AST 42 Tx start Sof/Dac 17Dec15.
SVR4 at 7Apr16 ALT 22 AST 22
SVR12 at 9Jun16 ALT 23 AST 25
Melbourne, Australia
Last Edit: 6 years 4 months ago by sonix.
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6120

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berrinice wrote:
I have just been diagnosed deficient B12 & folic acid associated with a) alcoholism or b) leukemia

Hi berrinice,

0.38% of 60mg daily is equivalent of 1/44,000 of a standard drink so the traces of ethanol in the Dac won't be the cause of the deficiencies. While it is associated with alcoholism the alcohol isn't the cause. Most likely it is a dietary deficiency, are you vegan or on a low animal product diet? Regardless, your GP needs to investigate it to determine the cause. Here is some info in relation to hep c.

hepatitiscnewdrugs.blogspot.com.au/2011/...nd-vitamin-b-12.html

G
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6128

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It is entirely usual that there are residual solvents present. They are the main reason that the purity is 99.x%

In the Daclatasvir we use the residual solvent is Ethyl Acetate CH3COOH (this is in nail polish remover and model airplane glue).

Ethanol is CH3CH2OH, and is a similar solvent.

If you think back to high school chemistry you probably remember dissolving crystal in liquid (solvent) and then mixing two things to make something else. This is the same as on industrial scale - the crystals of pure material are made in a solvent and it is increasingly expensive to remove all of it so we settle for 99.x% purity.
YMMV
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6141

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Hi Berrinice, My latest blood tests showed a b12 and folate deficiency aswell, it only turned up after starting ribavirin along with a couple of other unpleasant side effects, I've stopped the ribavirin, 24 weeks of Sof/Dac seems to work better without it in gen 3's anyway, but the ribavirin side effects continue to linger. And will take some time to leave my system. Ribavirin causes anemia which is also a factor in b12 and folate deficiency (according to what I've read) Are you taking ribavirin?
GT 3, F3, Contracted 1993 Tx Naive
V/L 1,267,000 AST 67 ALT 65 6/10/15
commence Sof/Dac (Mesochem) 6/11/15
AST ALT normal 24/11 *
*V/L UNDETECTED 24/11*
Last Edit: 6 years 4 months ago by crazy8.
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Residual Solvents in Certificate of Analysis 6 years 4 months ago #6143

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no riba for about 3 weeks. its not diet, meat eater. I had bristol myer squibb daclatasvir for 3 months, then bought in sydney after a couple of weeks I starting getting really tired again like with hep so I had thyroid and a blood test which showed b12 and folic acid deficiency, the only thing that changed was the source of declatasvir. Also I am not happy with the shoddy certificate of analysis that came with the meds.
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